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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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APACOL is a pilot, bicentric, randomised, open-label, prospective, category 2 study. The presence of colon cancer modifies blood lipid parameters which are likely to have an impact on the efficacy of anti-cancer treatments. Previous data support the hypothesis that appropriate physical activity could modify the blood lipid parameters involved in chemoresistance in patients with metastatic colorectal cancer.
The aim of the APACOL study is to investigate the impact of modulating the frequency (volume per week) of physical activity recommended by INCa on the variation in lipid parameters involved in chemoresistance in patients with metastatic colon cancer, with a reference level of these lipid parameters in people without cancer provided by the participation of volunteers who are not ill.
The expectations at the end of this study are an improvement in the patient's quality of life / an improvement in the tolerance and efficacy of the chemotherapy treatment / identification of the frequency of APAs needed to vary the lipid metabolism involved in chemoresistance.
This study will be open on 2 sites (CIC CHU Dijon with inclusion of 18 volunteers and CGFL with inclusion of 36 patients).
The participants will be randomized in 4 differents groups :
For patients in groups 1 to 3, participants will be asked to complete a diary to record their daily physical activity and the duration of that activity.
For groups 2 and 3, in addition to the diary, sessions with adapted physical activity teaching will be organised throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 - Arms without teacher intervention for adapted physical activity | Active Comparator | For this group:
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| Group 2 - Arm " intervention by an adapted physical activity teacher - minimum volume of INCa recomm | Active Comparator | For this group:
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| Group 3 - Arm " intervention by an adapted physical activity teacher - maximum volume of INCa recomm | Active Comparator | For this group:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipidomic analyses | Biological | 3 blood samples taken from 2 x 6 mL EDTA tubes for patients
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the impact of adapted physical activity on the concentration of complex lipids in a population of patients with metastatic colorectal cancer treated with chemotherapy. | The concentrations of complex lipids will be measured by high-performance liquid chromatography-mass spectrometry and by gas chromatography-mass spectrometry. The different concentrations of complex lipids will be compared between the 3 groups of patients (groups 1, 2 and 3) benefiting from a different frequency of adapted physical activity sessions. | For 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating and comparing adverse events linked to adapted physical activity | Safety will be assessed in the 3 physical activity groups according to NCI-CTCAE version 5.1 | 24 months |
| Evaluate and compare changes in patients' quality of life |
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Inclusion Criteria for patients:
Inclusion Criteria for healthy volunteers :
Exclusion Criteria for patients :
- Independent physical activity exceeding INCa recommendations: Moderate physical activity greater than or equal to 300 minutes/week (≥5h) or intense physical activity greater than or equal to 150 minutes/week (≥2.5h)).
Previous stroke Myocardial infarction in the 6 months prior to inclusion Uncontrolled arterial hypertension Severe cardiovascular or respiratory disease Rheumatological/orthopaedic conditions or bone lesions at risk of fracture
Exclusion Criteria for healthy volunteers :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Laure REROLE | Contact | 0345348846 | +33 | arerole@cgfl.fr |
| Name | Affiliation | Role |
|---|---|---|
| Dr Julie VINCENT | Centre Georges François Leclerc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges-François Leclerc | Dijon | 21000 | France |
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| Group 4 - Healthy volunteers | Active Comparator | For this group:
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| Adapted physical activity program | Other | 8-week adapted physical activity program. This program will be adapted to each group |
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Quality of life will be assessed in the 3 physical activity groups by the quality of life questionnaire (FACT-C) at inclusion, at 4 weeks and at the end of 8 weeks of physical activity follow-up. This questionnaire is numbered from 0 to 4 (0 is the best case / 4 is the worst case).
This questionnaire informe on the physical well-being, familial well-being, emotional well-being, functional well-being.
| During 8 weeks |
| Prospective collection of biological plasma samples | All samples are kept in order to analyze the expression of a marker of interest in a subpopulation of immune cells not included in the study panels a posteriori. | During 8 weeks |
| Progression-free survival | Disease response will be described at each evaluation. | 24 months |
| Overall survival | Overall survival will be defined as the time elapsed between inclusion and death from any cause. | 24 months |
| CHU Dijon (clinical investigation centre) | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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